Kornimate/medical-research-clean huggingface dataset:
observation of the implementation of a bundle of care in colorectal surgery to reduce surgical site infections successfully

Conditions: Reduction of Surgical Site Infections in Colorectal Surgery

Summary: this study aims to evaluate whether the colorectal bundle designed and implemented at cantonal hospital lucerne, will lead to a significant reduction of ssis. the impact of potential risk factors for ssis will additionally be evaluated.

surgical site infections (ssis) remain a relevant problem in colorectal surgery. the aim of this study is to implement a bundle of care in order to reduce ssis in colorectal surgery. all patients undergoing colorectal surgery between october 2018 and september 2021 will be included in a prospective observational study. since our colorectal bundle has been established gradually, patients will be grouped in a pre-implementation (2018-2019), implementation (2019-2020) and post implementation phase (2020-2021), in order to assess the effectiveness of the actions undertaken. primary endpoint of this study will be surgical site infection (ssi) rate, while secondary endpoints encompass potential risk factors for ssis. we assume that obesity, age, diabetes, alcoholism and smoking may lead to a higher risk for ssis.

Eligibility criteria:
inclusion criteria: over 18 elective or emergency colorectal surgery written informed consent exclusion criteria: pregnant no informed consent

Keywords: colorectal surgery bundle of care surgical site infection
an open label extension study of the safety and clinical utility of ipx066 in subjects with parkinson's disease

Conditions: Parkinson's Disease

Summary: the purpose of this study is to determine the long term safety and clinical utility of ipx066 in subjects with parkinson's disease.

ipx066 is intended for chronic treatment of motor symptoms for all stages of pd. this study is designed to enroll subjects who have successfully completed one of the following studies of ipx066: * ipx066-b08-05 (a placebo-controlled study to evaluate the safety and efficacy of ipx066 in subjects with parkinson's disease) * ipx066-b08-11 (a study to compare pharmacokinetics and pharmacodynamics of ipx066 to standard carbidopa - levodopa) * ipx066-b09-02 (a study to evaluate the safety and efficacy of ipx066 in advanced parkinson's disease) all participants will be given ipx066 for 9 months.

Eligibility criteria:
inclusion criteria: * each subject must meet the following inclusion criteria in order to be enrolled in the study: 1. successful completion of studies ipx066-b08-05, ipx066-b08-11, or ipx066-b09-02. 2. in the opinion of the investigator, the parkinson's disease diagnosis is still valid and the subject remains eligible for ld therapy. exclusion criteria: * each subject must be free of the following exclusion criteria in order to be enrolled in the study: 1. received an investigational medication other than those from an ipx066 trial within 4 weeks prior to the planned start of treatment. 2. anticipates functional neurosurgical treatment for pd (e.g., ablation or deep brain stimulation) during study participation. 3. received within 4 weeks prior to baseline visit or planning to take during study participation: nonselective monoamine oxidase (mao) inhibitors (with the exception of rasagiline). 4. in the opinion of the investigator, should not participate in the study.

Keywords: motor symptoms efficacy ipx066 parkinson's disease
clinical trial to assess the efficacy and safety of yyd601 in nerd patients

Conditions: Non-erosive Reflux Disease

Summary: clinical trial to assess the efficacy and safety of yyd601 in nerd patients

this phase 3 clinical trial is designed as randomized, double-blind, placebo-controlled, multi-centers clinical trial to assess the efficacy and safety of yyd601 in nerd patients (phase3).

Eligibility criteria:
inclusion criteria: * a man or woman over 20 years old less than 70 years old. * a man or woman who has below all characters and diagnosis as nerd. 1. a man or woman who has experienced symptom(hearburn or/and acid regurgitation) over 3month at least. 2. a man or woman who has experienced symptom(heartburn or/and acid regurgitation) within 7days before visit1, meet below 1) or 2) criteria. \*\* symptom (heartburn and acid regurgitation) is confirmed by rdq * experienced above 2 days in a week, heartburn of acid regurgitation above the weakness. * experienced above 1 day in a week, heartburn of acid regurgitation above the middle. 3. a man or woman who has been made diagnosis as la grade0(zero) measured through the dendoscopy which is corried out within 14 days, there is no observed muscosal break. * a man or woman who has a full understanding of this clinical trial through the detailed explanation, agree in writing to participate in this trial. exclusion criteria: * who has hyper sensitivity reaction about other drugs, ingredients, components of investigator product or compound of benzimidazole. * who has erd. * who get a diagnosis as a ibs within the last 3 months. * who have taken drugs about reflux esophagitis (h₂-receptor inhibitor (h2ra) prostaglandin(pg), antacid, prokinetic acid etc.) above 2 times as an usual dose. (\* refer to the concomitant medication in text.) * who havbe taken gastric acid secretion inhibitors including ppis within 2 weeks before the endoscopy. * who has been experienced the disease affecting the esophagus(eosinophilic esophagitis, esophageal varices, cirrhosis, virus or fungal infection, esophageal stricture, primary esophageal motility disorder and gastrointestinal bleeding). or who has a history of radio therapeutics, freeze treatment about the esophagus. * who has the gastric or duodenal ulcer, zollinger-ellison and other acid hypersecretory condition been experienced. * who has hyper-sensitivity, reaction about ppis (ex. lansoprazole, omeprazole, rabeprazole, pantoprazole or esomeprazole). * who has gotten a diagnosis as a cancer within 5 years before participated in this clinical trail (expect the basal cell on the skin), peptic ulcer or benign tumor.
pomegranate juice in treating patients with recurrent prostate cancer

Conditions: Prostate Cancer

Summary: rationale: pomegranate juice may contain substances that decrease or slow the rise of prostate-specific antigen (psa) levels and may be effective in delaying or preventing recurrent prostate cancer. purpose: this phase ii trial is studying how well pomegranate juice works in decreasing or slowing the rise of psa levels in patients who have undergone radiation therapy or surgery for prostate cancer.

objectives: * determine whether pomegranate juice can decrease or slow rising prostate-specific antigen (psa) levels in patients who have undergone radical prostatectomy or radiotherapy for adenocarcinoma of the prostate. outline: patients receive oral pomegranate juice once daily. treatment continues for 18 months in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 29-40 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate * must have undergone prior surgery or radiotherapy for the primary tumor * documented rising prostate-specific antigen (psa) level, defined by the following criteria: * absolute level of psa at least 0.2 ng/ml but less than 5.0 ng/ml * rising psa level must be confirmed at least 1 week later * adequate psa time points to calculate a psa doubling time * gleason score no greater than 7 * age 18 and over * performance status ecog 0-1 * life expectancy at least 6 months * no other malignancy within the past 5 years except nonmelanoma skin cancer * no other serious concurrent systemic medical disorders that would preclude study compliance * no known allergy to pomegranate juice * more than 4 weeks since prior participation in another experimental study exclusion criteria: * nodal involvement * evidence of metastatic disease * prior hormonal therapy * concurrent hormonal therapy for rising psa levels after initial therapy for prostate cancer * concurrent participation in another experimental study * other concurrent systemic or local therapy for prostate cancer * initiation or discontinuation of any new nutritional or dietary supplements during study participation

Keywords: adenocarcinoma of the prostate recurrent prostate cancer
incb028050 compared to background therapy in patients with active rheumatoid arthritis (ra) with inadequate response to disease modifying anti-rheumatic drugs

Conditions: Rheumatoid Arthritis

Summary: this was a randomized, double blind, placebo controlled, dose ranging, parallel group study. participants who had active rheumatoid arthritis (ra) who had inadequate response to any disease modifying anti-rheumatic drug (dmard) therapy including biologics were enrolled. screening evaluations were performed within approximately 28 days of randomization. the duration of the study was 6 months with the primary endpoint assessed at 3 months. eligible participants were randomly assigned to one of three doses (4, 7 or 10 mg qd) of incb028050 (baricitinib) or placebo.


Eligibility criteria:
inclusion criteria: * must have rheumatoid arthritis which has been inadequately controlled with at least one dmard * for subjects receiving antimalarials, they must be treated with antimalarials for at least 6 months and receiving a stable daily dose * for subjects receiving sulfasalazine, they must be treated with sulfasalazine (ssz) for at least 6 months and receiving a stable daily dose of no more than 3 grams per day * for subjects on methotrexate, they must be treated with methotrexate for at least 6 months, and receiving a stable weekly dose of methotrexate between 7.5 and 25 mg * for subjects on leflunomide, they must be treated with leflunomide for at least 6 months, and receiving a stable dose of leflunomide between 10 to 20 mg * for subjects receiving corticosteroids, they must be on a dose not to exceed 10 mg of prednisone daily * active rheumatoid arthritis at the time of screening defined by the following: 6 or more joints tender or painful on motion and 4 or more swollen joints and at least one of the following two: erythrocyte sedimentation rate (esr) greater than or equal to 28 mm/hr or c-reactive protein (crp) greater than or equal to 7 mg/liter * have evidence of lack of risk for tuberculosis exclusion criteria: * current or recent viral, bacterial, fungal, parasitic or mycobacterial infection requiring systemic therapy * history of infected joint prosthesis * subjects who have a current or recent history of severe, progressive, uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease * subjects who have received treatment with the following drugs or drug classes within the specified timeframe: prior treatment with rituximab within 12 months, prior treatment with an oral janus kinase (jak) inhibitor, dmards or other anti-rheumatic therapies not specified and allowed according to protocol, treatment with any investigational medication within 12 weeks or 5 half-lives (whichever is longer), and treatment with a biologic agent within 12 weeks prior to the first dose of study medication * subjects with a past history of neutropenia, thrombocytopenia or anemia requiring transfusion other than at the time of trauma or surgery, and subjects that meet protocol specified laboratory measures

Keywords: rheumatoid arthritis
trans-inguinal pre-peritoneal hernioplasty versus lichtnestein's technique in inguinal hernia repair

Conditions: Inguinal Hernia

Summary: mesh repair of inguinal hernia is the most common operation performed on general surgical patients. approximately 20 million groin hernioplasties are performed each year worldwide. countless studies have been reported in the medical literature in attempts to improve the overall outcomes following hernia operations and, due to this fact, the procedure has evolved immensely, especially over the last few decades. recurrence of inguinal hernia was initially a significant problem. lichtenstein repair (lr), recurrence rate has consistently been reported as low as 1-4%\[2\], a drop from up to 10%. but increased incidence of chronic groin pain following lr. transinguinal preperitoneal (tipp) inguinal hernia repair with soft mesh has been reported as a safe anterior approach with a preperitoneal mesh position . theoretically, tipp repair may be associated with lesser chronic postoperative pain than lichtenstein's technique due to the placement of mesh in the preperitoneal space to avoid direct regional nerves dissection and their exposure to bio-reactive synthetic mesh. the placement of mesh in this plane without using any suture for fixation and lack of mesh exposure to regional nerves was assumed to result in the reduced risk of developing chronic groin pain. so aim of our study to prove less hospital stay and complication and cost effectiveness for preperitoneal meshplasty

this study is a prospective randomized study including all patients with unilateral non complicated inguinal hernia who will undergo hernioplasty in surgery department at auh during the period from 3- 2018 to 6- 2020 methodology: patients will be classified into two groups according to the surgical procedure performed as follows: * group a: patients undergoing tipp hernioplasty * group b: patients undergoing lichtnestein's technique hernioplasty sample size:15 patients for each group. d) exclusion criteria: 1. patients who were unfit for operation. 2. patients with bilateral or recurrent inguinal hernia 3. patients aged below 18 years, 4. patients undergoing emergency hernia repairs

Eligibility criteria:
inclusion criteria: * . patients with unilateral non complicated inguinal hernia who will undergo hernioplasty in surgery department at auh exclusion criteria: 1. patients who were unfit for operation. 2. patients with bilateral or recurrent inguinal hernia 3. patients aged below 18 years, 4. patients undergoing emergency hernia repairs
a study to evaluate the long-term safety of tak-771 in japanese primary immunodeficiency disease (pid) participants

Conditions: Primary Immunodeficiency Diseases (PID)

Summary: the main aim of the study is to check side effect from the study treatment with tak-771 in long term. participants can have taken part in the previous study tak-771-3004 (nct05150340). for those who can take part, the participants will receive injections of tak-771 after the end of the previous study. the participants will be treated with tak-771 for totally 3 years. there will be many clinic visits. the number of visits will depend on the infusion cycles of study drug.


Eligibility criteria:
inclusion criteria: 1. participant have completed or is about to complete study tak-771-3004 (nct05150340). 2. written and/or electronic informed consent is obtained from either the participant or the participant's legally authorized representative prior to any study-related procedures and study product administration. if a participant is \<18 years of age, written and/or electronic informed consent should also be obtained from the participant's legally authorized representative in addition to written informed assent by a participant if appropriate. 3. participant is willing and able to comply with the requirements of the protocol. exclusion criteria: 1. participant has developed a new serious medical condition during study tak-771-3004 such that the participant's safety or medical care would be impacted by participation in the study. 2. participant is willing to participate in other clinical trials. 3. women of childbearing potential who meet any one of the following criteria: 1. participant presents with a positive pregnancy test. 2. participant does not agree to employ adequate birth-control measures (eg, intrauterine device, condom \[for male partner\], or birth-control pills) throughout the course of the study.
study to estimate the burden of herpes zoster and postherpetic neuralgia in spain

Conditions: Herpes Zoster

Summary: the purpose of this study is to collect data on the incidence, complications and impact on quality of life of herpes zoster (hz) disease in adults \>=50 years of age in spain. this study will also collect data on costs related to the hz disease, especially postherpetic neuralgia (phn)


Eligibility criteria:
inclusion criteria: * a male or female \>=50 years of age at the time of study enrolment presenting with acute hz; * hz diagnosis for this hz episode; * is the subject's first outpatient diagnosis; or * took place at another site/ centre up to seven days before the initial visit for the present study; * ability to comply with study procedures\*; * written informed consent obtained from the subject\*. note: \* will be applicable to secondary objectives only and not for the primary objective to calculate incidence. exclusion criteria: • subject participating in another research study. note: this exclusion criteria is applicable to secondary objectives only and not for the primary objectives to calculate incidence.

Keywords: spain cost complications incidence adults quality of life herpes zoster surveillance
free fatty acids-induced hypertension in obese subjects (aim #2)

Conditions: Hypertension; Diabetes

Summary: the purpose of this study is to see if salsalate, an nuclear factor-kappab (nf-κb) mediated inflammation inhibitor, or carvedilol, an α- and β-blocker, will protect against free fatty acid induced hypertension, insulin resistance, endothelial dysfunction, inflammation and oxidative stress, and autonomic dysfunction in obese normotensive subjects.

during postprandial lipemia, dietary triglycerides transported by intestinal chylomicrons are hydrolyzed by lipoprotein lipase lining the vascular bed, with subsequent release of ffa for transport across the endothelium. whether the intermittent flux of ffa has the same impact as the i.v. lipid infusion will be examined. decreased endothelial function has been reported after a single or long-term dietary high fat load in normal subjects; however, others have found no effects on brachial artery vasoreactivity. our preliminary studies indicate that high oral fat loads (60 g) resulted in higher ffa levels and bp changes, and reduced fmd compared to low fat load (25 g).

Eligibility criteria:
inclusion criteria: * males or females * obese subjects (body mass index (bmi) ≥ 30 kg/m\^2) * 18 and 65 years * blood pressure reading \< 140/80 mm hg and no prior history of hypertension exclusion criteria: * history of diabetes mellitus * history of hypertension * fasting triglyceride levels \> 250 mg/dl * liver disease (alt 2.5x \> upper limit of normal) * serum creatinine ≥1.5 mg/dl * smokers, drug or alcohol abuse * mental condition rendering the subject unable to understand the scope and possible consequences of the study * female subjects who are pregnant or breast feeding
multimodal imaging of hypoxia in gliomas

Conditions: Glioma

Summary: the imaging of cerebral oxygenation is an extremely important tool in understanding the pathophysiology of the tumor and for adaptation of therapies according to hypoxia. currently, imaging of cerebral oxygenation is mainly performed by the use of positron emission tomography (pet). thus, the investigators have been able to show that the fmiso radiotracer can reveal tumor hypoxia (hyponco study, promotor: caen university hospital, main investigator: j.s. guillamo). after injection of the radiotracer, increased uptake is observed in the regions for which the tissue oxygen pressure is less than 10 mmhg (the healthy brain with a tissue oxygen pressure (pto2) ≈ 40mmhg). although pet is a reference methodology, it is not widely practiced mainly because of radioactive sources. magnetic resonance imaging (mri) would bypass the previously mentioned pet limitations. the investigators have recently shown that a measure of local oxygen saturation could be obtained by mri. this methodology has also been implemented at a clinical scale on lower field mri magnets, but its formal validation in a clinical situation remains to be demonstrated with respect to fmiso. the major advantage of this methodology is that mri is already performed in routine practice for patients. measuring tissue oxygenation with mri (sato2-mri) would not add additional examination for the patient. in addition, mri is a non-ionizing methodology with a very good spatial resolution compared to pet, this should help to better understand intratumoral heterogeneity. similarly, in preclinical studies, the investigators have shown in a context of mild hypoxia that sato2-mri may be more sensitive than pet. the investigators propose a study to compare in patients with glial tumors, images obtained by 3 tesla mri of sato2-mri to the hypoxia maps obtained by fmiso pet. these imaging studies will be confronted with studies carried out in immunohistochemistry on biopsies / resection allowing to reveal and to quantify by image analysis the expression of the factors induced by hypoxia (hif1, hif2). this study should include 20 patients with glioma (15 high-grade patients and 5 low-grade patients) in pre-surgery. the aim is to show that sato2-mri is a relevant methodology (in terms of sensitivity, specificity) for assessing intratumoral oxygenation in a context of brain tumors. this fits perfectly into an era of personalized medicine where functional imaging finds its meaning.


Eligibility criteria:
inclusion criteria: * adult patient (\> 18 years-old) * patient with a diffuse glioma (astrocytoma or oligodendroglioma or glioblastoma) * karnofsky index ≥ 70% * patient able to understand and sign the consent or accompanied by a trusted person who can do so * normal blood test with results: neutrophil ≥ 1500 cells / μl, platelets ≥ 100,000 μl, serum glutamic-oxaloacetic transaminase (sgot) ≤ 2.5 x upper normal limit (unl), creatine ≤ 1.5 x unl * patient affiliated to a social security exclusion criteria: - patient with contraindications to surgery

Keywords: mri hypoxia o2 saturation fmiso pet glioma